BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2311998 · Received October 27, 2011

    Report

    Report Number
    2122870-2011-04846
    Event Type
    Injury
    Date Received
    October 27, 2011
    Date of Event
    September 29, 2011
    Report Date
    October 4, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHA
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THE CUSTOMER REPORTED THAT THEIR BIOMEDICAL ENGINEER WOULD PROVIDE INSTRUMENT HARDWARE VERIFICATION. THERE WERE NO REPORTS OF THE REPAIRS, IF ANY, PERFORMED ON THE INSTRUMENT BY THE CUSTOMER'S BIOMEDICAL ENGINEER, HOWEVER FOR THE PURPOSE OF THIS REPORT AN INSTRUMENT MALFUNCTION WILL BE ASSUMED. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT TO DATE. ASSOCIATED MDRS: 2122870-2011-04846, 2122870-2011-05026, 2122870-2011-04943, 2122870-2011-04942, 2122870-2011-04847.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUS/IMPRECISE HUMAN CHORIONIC GONADOTROPIN (BHCG), CARDIAC TROPONIN (ACCUTNI) AND CREATINE KINASE-MB ISOENZYME (CK-MB) RESULTS WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR MULTIPLE PATIENT SAMPLES. THIS IS REPORT ONE OF FIVE AND REPRESENTS THE ERRONEOUS BHCG RESULT GENERATED FOR ONE PATIENT ON (B)(6) 2011. BECKMAN COULTER INC ASSESSMENT OF THE CUSTOMER SUPPLIED DATA INDICATED THAT THE INITIAL PATIENT RESULT WAS A FALSE POSITIVE BHCG PATIENT RESULT ABOVE THE NORMAL REFERENCE RANGE OF THE ASSAY. THIS INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND IN RESPONSE TO THIS FALSE RESULT THE PATIENT WAS TOLD THEY WERE PREGNANT AND THEY WERE ADMINISTERED MEDICATION. IT IS UNKNOWN WHAT MEDICATION WAS ADMINISTERED. SUBSEQUENTLY, THE PATIENT WAS RE-DRAWN AND THE SAMPLE WAS TESTED ON THE SAME INSTRUMENT IN DILUTED AND UNDILUTED FORM. THE SECOND SAMPLE'S BHCG AND DILBHCG RESULTS WERE NEGATIVE, PROMPTING A REPEAT OF THE INITIAL SAMPLE RESULT. UPON REPEAT OF THE INITIAL SAMPLE ON THE SAME INSTRUMENT IN DILUTED AND UNDILUTED FORM, THE REPEAT BHCG AND DILBHCG RESULTS WERE NEGATIVE AS WELL. NO PATIENT DEMOGRAPHIC INFORMATION OR SAMPLE COLLECTION/HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER. THE INSTRUMENT BHCG QUALITY CONTROL RESULTS RECOVERED WITHIN CUSTOMER SPECIFICATION ON THE DATE OF THE EVENT AND SYSTEM CHECKS PERFORMED PRIOR TO THE EVENT PASSED WITHIN INSTRUMENT SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY DHA BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ACCESS TOTAL SSHCG REAGENT